Devices and methods for performing procedures on a breast

ABSTRACT

A guide element is used to guide a cutting device when removing breast tissue. The cutting device may have a tissue collection element for collecting tissue. The tissue collection element may be detachable so that the collection element may be removed independent from the cutting device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.11/740,855 filed Apr. 26, 2007 (now abandoned), which is a divisional ofU.S. application Ser. No. 10/923,511 filed Aug. 20, 2004, now U.S. Pat.No. 7,517,348, which is a continuation-in-part of U.S. application Ser.No. 10/732,670 filed Dec. 9, 2003, now U.S. Pat. No. 7,329,253, which isa continuation-in-part of U.S. application Ser. No. 10/272,448 filedOct. 16, 2002, now U.S. Pat. No. 6,936,014, which is acontinuation-in-part of U.S. application Ser. No. 10/796,328 filed Mar.8, 2004, now U.S. Pat. No. 7,303,531, which is a continuation of U.S.application Ser. No. 09/417,520 filed Oct. 13, 1999, now U.S. Pat. No.6,423,081, which is a divisional of U.S. application Ser. No. 09/146,743filed Sep. 3, 1998 now U.S. Pat. No. 6,022,362.

BACKGROUND OF THE INVENTION

Breast cancer is a major threat and concern to women. Early detectionand treatment of suspicious or cancerous lesions in the breast has beenshown to improve long term survival of the patient. The trend is,therefore, to encourage women not only to perform monthly self-breastexamination and obtain a yearly breast examination by a qualifiedphysician, but also to undergo annual screening mammography commencingat age 40. Mammography is used to detect small, nonpalpable lesionswhich may appear opaque densities relative to normal breast parenchymaand fat or as clusters of microcalcifications. The conventional methodfor diagnosing, localizing and excising nonpalpable lesions detected bymammography generally involves a time-consuming, multi-step process.First, the patient goes to the radiology department where theradiologist finds and localizes the lesion either using mammography orultrasound guidance. Once localized, a radio-opaque wire is insertedinto the breast. The distal end of the wire may include a small hook orloop. Ideally, this is placed adjacent to the suspicious area to bebiopsied. The patient is then transported to the operating room.

Under general or local anesthesia, the surgeon may then perform aneedle-localized breast biopsy. In this procedure, the surgeon, guidedby the wire previously placed in the patient's breast, excises a mass oftissue around the distal end of the wire. The specimen is sent to theradiology department where a specimen radiograph is taken to confirmthat the suspicious lesion is contained within the excised specimen.Meanwhile, the surgeon, patient, anesthesiologist and operating roomstaff, wait in the operating room for confirmation of that fact from theradiologist before the operation is completed. The suspicious lesionshould then be excised in toto with a small margin or rim of normalbreast tissue on all sides. Obtaining good margins of normal tissueusing conventional techniques is extremely dependent upon the skill andexperience of the surgeon, and often an excessively large amount ofnormal breast tissue is removed to ensure that the lesion is locatedwithin the specimen. This increases the risk of post-operativecomplications, including bleeding and permanent breast deformity. As 80%of breast biopsies today are benign, many women unnecessarily sufferfrom permanent scarring and deformity from such benign breast biopsies.

More recently, less invasive techniques have been developed to sample orbiopsy the suspicious lesions to obtain a histological diagnosis. Thesimplest of the newer techniques is to attempt visualization of thelesion by external ultrasound. If seen by external ultrasound, thelesion can be biopsied while being continuously visualized. Thistechnique allows the physician to see the biopsy needle as it actuallyenters the lesion, thus ensuring that the correct area is sampled.Current sampling systems for use with external ultrasound guidanceinclude a fine needle aspirate, core needle biopsy or vacuum-assistedbiopsy devices.

Another conventional technique localizes the suspicious lesion usingstereotactic digital mammography. The patient is placed prone on aspecial table that includes a hole to allow the breast to dangletherethrough. The breast is compressed between two mammography plates,which stabilizes the breast to be biopsied and allows the digitalmammograms to be taken. At least two images are taken 30 degrees apartto obtain stereotactic views. The x, y and z coordinates targeting thelesion are calculated by a computer. The physician then aligns a specialmechanical stage mounted under the table that places the biopsy deviceinto the breast to obtain the sample or samples using fine needleaspiration, core needle biopsy, vacuum-assisted core needle biopsy orother suitable method. Fine needle aspiration uses a small gauge needle,usually 20 to 25 gauge, to aspirate a small sample of cells from thelesion or suspicious area. Core needle biopsy uses a larger size needle,usually 14 gauge to sample the lesion. Tissue architecture and histologyare preserved with this method. Multiple penetrations of the core needlethrough the breast and into the lesion are required to obtain anadequate sampling of the lesion. Over 10 samples have been recommendedby some. The vacuum-assisted breast biopsy system is a largersemi-automated side-cutting device. It is usually 11 gauge in diameterand is more sophisticated than the core needle biopsy device. Multiplelarge samples can be obtained from the lesion without having to reinsertthe needle each time. A vacuum is added to suck the tissue into thetrough. The rapid firing action of the spring-loaded core needle deviceis replaced with an oscillating outer cannula that cuts the breasttissue off in the trough. The physician controls the speed at which theouter cannula advances over the trough and can rotate the alignment ofthe trough in a clockwise fashion to obtain multiple samples.

If a fine needle aspirate, needle core biopsy or vacuum-assisted biopsyshows malignancy or a specific benign diagnosis of atypical hyperplasia,then the patient needs to undergo another procedure, the traditionalneedle-localized breast biopsy, to fully excise the area with anadequate margin of normal breast tissue. Sometimes the vacuum-assisteddevice removes the whole targeted lesion. If this occurs, a smalltitanium clip should be placed in the biopsy field. This clip marks thearea if a needle-localized breast biopsy is subsequently required forthe previously mentioned reasons.

Another method of biopsying the suspicious lesion utilizes a largeend-cutting core device measuring 0.5 cm to 2.0 cm in diameter. Thisalso uses the stereotactic table for stabilization and localization.After the lesion coordinates are calculated and local anesthesiainstilled, an incision large enough is permit entry of the bore is madeat the entry site with a scalpel. The breast tissue is cored down to andpast the lesion. Once the specimen is retrieved, the patient is turnedonto her back and the surgeon cauterizes bleeding vessels under directvision. The incision, measuring 0.5 to larger than 2.0 cm is suturedclosed. The newer conventional minimally invasive breast biopsy deviceshave improved in some ways the ability to diagnose mammographicallydetected nonpalpable lesions. These devices give the patient a choice asto how she wants the diagnosis to be made.

SUMMARY OF THE INVENTION

In one aspect of the present invention, a tissue cutting device havingan elongate cutting element is advanced adjacent to tissue to beremoved. The cutting element is then expanded and moved through thebreast tissue to cut the breast tissue. The tissue is then removed usinganother device which may be introduced through a separate penetration inthe breast. An advantage of this procedure is that the user may selectone site for introduction of the cutting device while another site wouldbe better suited for removal of the tissue. The removal incision may bepartially or completely created by the cutting element or may be createdby the removal device.

The tissue cutting device may also encapsulate the tissue in a tissuecollection element. The tissue collection element may be releasable sothat it can be removed through a separate incision. The collectionelement and removal element may engage one another with a mechanical ormagnetic connection or may use suction to adhere the removal element tothe collection element.

The present invention is also directed to a cutting device having acutting element which bows outwardly when in the expanded position. Thecutting element moves generally in a first plane when moving between thecollapsed and expanded positions. The cutting device may also have anasymmetrical shaft with a first thickness and a second thicknessrelative to the central axis of the shaft. The first and secondthicknesses lie in a second plane which is generally parallel to thefirst plane with the second thickness being at least 1.25 or even atleast 1.5 times larger than the first thickness with the side of theshaft having the second thickness leading the cutting element duringrotation. Stated another way, the shaft may be at least 1.25 timesthicker, or even at least 1.5 times thicker, on a leading side than on atrailing side as defined by the direction of rotation of the cuttingelement.

The present invention is also directed to a method of cutting tissueusing a guide element. The guide element guides introduction andadvancement of the cutting device. The guide element also may indicate acutting parameter such as an indication of a depth of penetration duringthe advancing step or one or more angular positions relative to the axisof rotation or longitudinal axis of the guide element. The guide elementmay also be secured to the tissue using a suitable anchor such as barbs,an adhesive strip or an inflatable element on the guide.

In still another aspect of the present invention, the tissue cuttingelement is marked at a first location corresponding to a position on thecutting element where an apex occurs when the cutting element is bowedoutwardly. The marker, such as an ultrasound marker, helps the user toidentify where the apex of the cutting element will be when the cuttingelement expands since the middle of the cutting element does notnecessarily become the apex of the cutting element when expanded.

In another aspect of the present invention, a guide element isintroduced into the breast and is used to guide a device such as atissue cutting device or a tissue removal device. The guide element mayprovide indications as to the area of the breast tissue to be removed.For example, the guide element may have depth markers or may have theindicators described above which mark angular positions. The guideelement may also constrain the cutting device with a longitudinal stopand one or more angular stops which prevent rotation beyond one or moreangular positions. When removing tissue, the cutting device may alsohave a collection element, such as a bag, which collects the severedtissue for removal.

The present invention is also directed to a method and device forremoving tissue from a breast by excising the breast tissue using atissue cutter extending through one incision and then removing theexcised tissue through a separate incision. The removal device may be avacuum device or other suitable device for grasping the tissue. Inanother aspect, the tissue may be contained in a tissue collectionelement. The collection element may have a tether which is used to helpretrieve the collection element and tissue.

The cutting element and shaft may cooperate to facilitate parting offthe excised tissue to complete the cut. The cutting element movesgenerally in a first plane relative to the shaft when expanding. Theshaft is preferably thicker on the leading side of the shaft, whichleads the cutting element during rotation, than on the trailing side ofthe shaft. For example, the thicker part of the shaft may be within thefirst 90 degrees on the leading side so that the thicker part of theshaft lies just ahead of the cutting element during rotation.

In another aspect of the present invention, a guide member is used tointroduce and guide the cutting device. The guide member may be fixed inposition to hold the angular orientation or depth of penetration of theguide member to guide the cutting device. The guide member may also havea window which further limits and defines the cutting procedure.

The cutting device may also have ultrasound markers which are used toposition and locate the device before and during the cutting procedure.A first marker on the cutting element corresponds to a position on thecutting element where an anticipated apex occurs when the cuttingelement is bowed outwardly. The guide member may also have a markercorresponding to the anticipated longitudinal position of the apex ofthe cutting element so that the guide member may be positionedappropriately.

These and other aspects of the present invention will become apparentfrom the following drawings and description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a needle made in accordance with the present invention.

FIG. 2 shows a tissue removing device.

FIG. 3 shows the needle introduced into a breast.

FIG. 4 shows a first anchor deployed within the breast.

FIG. 5 shows a second anchor deployed within the breast.

FIG. 6 shows a stiffener removed to provide a flexible proximal end.

FIG. 7 shows the flexible, proximal portion taped to the breast.

FIG. 8 shows a tissue removing device advanced over the needle and acutting element deployed.

FIG. 9 is a perspective view of a combination introducer and suctionsleeve, according to another embodiment of the present invention.

FIG. 10 is a side cross-sectional view of the combination introducer andsuction sleeve of FIG. 9.

FIG. 11 is a perspective view of the combination introducer and suctionsleeve of FIG. 9, with a trocar inserted therein.

FIG. 12 is a side cross-sectional view of the combination introducer andsuction sleeve of FIG. 9, illustrating exemplary structure with whichthe suction sleeve may attach to the interventional device.

FIG. 13 is a perspective cross-sectional view of the combinationintroducer and suction sleeve, attached to an exemplary interventionaldevice

FIG. 14 is a perspective view of another embodiment of a suction sleeveaccording to the present invention, coupled to an exemplaryinterventional device.

FIG. 15 shows another guide element used to introduced a cutting deviceinto the tissue.

FIG. 16 shows a piercing element removed from a lumen in the guidemember.

FIG. 17 shows a cutting device introduced into the guide element.

FIG. 18 shows guide member retracted and anchored to the tissue withneedles and an adhesive tape.

FIG. 19 is a perspective view of the cutting device and the guidemember.

FIG. 20 shows a tube which is cut to form a lip.

FIG. 21 is a cross-sectional view of FIG. 20 along line I-I.

FIG. 22 shows the tube of FIG. 20 covered with a shrink tube.

FIG. 23 is a cross-sectional view of FIG. 22 along line II-II with theaddition of a cutting element shown in an expanded or bowedconfiguration.

FIG. 24 is a cross-sectional view of FIG. 22 along line III-III.

FIG. 25 shows another device for cutting or incising tissue.

FIG. 26 shows a removable core.

FIG. 27 is a cross-sectional view of the device of FIG. 25 along lineA-A.

FIG. 28 shows the removable core positioned within a sheath.

FIG. 29 shows the cutting or incising device positioned within thesheath.

FIG. 30 shows the cutting device positioned so that the cutting elementwill sweep around the tissue area being removed.

FIG. 31 shows a tissue removal device introduced through anotherincision.

FIG. 32 shows the tissue removal device attached to the tissue.

FIGS. 33-35 show use of the tissue cutting device to create a path forremoving the tissue.

FIG. 36 shows the cutting device used to penetrate the tissue to createa tissue removal incision.

FIG. 37 shows the tissue contained within a tissue collection elementhaving a tether which is coupled to the tissue cutter.

FIG. 38 shows the tissue cutter removed with the tether extending fromthe excised tissue.

FIG. 39 shows a side view of a tissue cutting device adjacent a tissuearea to be removed.

FIG. 40 shows the cutting element beginning to sweep around the tissuearea.

FIG. 41 shows the cutting element partially retracted to trap tissuebetween the cutting element and the shaft of the device.

FIG. 42 shows the tissue cutting device marking the tissue.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to FIGS. 1-8, a needle 2 may be used to guide another medicaldevice, such as a tissue cutting device 6, when performing a procedureon the breast. Any suitable tissue cutting device may be used such asthe devices disclosed in U.S. Pat. Nos. 6,440,147 and 6,022,362 whichare also hereby incorporated by reference. The tissue cutting device 6has a cutting element 8 capable of assuming positions between collapsedand bowed positions. The tissue cutting device 6 is pivoted or rotatedso that the cutting element 8 sweeps through and cuts the tissue alongan arc. A tissue collection element 10 may also be provided whichcollects the tissue being cut. The needle 2 may also include a stiffener4 which is used in the manner described in application Ser. No.10/272,448, filed Oct. 16, 2002, which has been incorporated herein byreference.

The needle 2 may also have one or more indicators 14 to mark an angularposition relative to the longitudinal axis 16 of the needle 2. Theindicator 14 extends radially outward from the needle at a angleselected by the user. The indicator 14 may also simply be a longitudinalstripe 18 or other marking on the shaft which indicates a particularangular orientation on the needle 2. The indicator 14 may provideinformation to the user regarding various parameters depending upon theprocedure being performed. For example, when using the device 6described above, the angular position, or positions, provides the userwith the angular extent of the tissue to be removed.

The indicators 14 may be coupled to one more anchors 20 which aredeployed to anchor the needle 2. The anchor 20 is preferably curved,such as J- or C-shaped, and extends radially to lie within the sameangular orientation as the indicator 14. An advantage of coupling theindicator 14 to the anchor 20 is that anchor 20 itself providesinformation regarding the relative orientation or the needle 2, anchor20 and tissue area of interest. Thus, the anchor 20 itself may be one ofthe indicators 14. Although the anchor 20 and indicator 14 arepreferably aligned at the same angular orientation, they may also beoffset to account for the geometry of other devices used with the needle2. As can be appreciated, of course, the indicators 14 may also beindependent of any anchoring elements. For example, the needle 2 may beplaced in the breast and the indicators 14 could then be moved toselected angular position(s). The needle 2 may also have depth markers22 along the body. The anchor 20 is preferably a stainless steel wirehaving a sharpened tip to pierce through the tissue. The orientation ofthe anchor 20 is partially guided by the geometry of the arc-shapedlumens (not shown) receiving the anchors 20.

Use of the device is now described in connection with a tissue removalprocedure with reference to FIGS. 1-8. Of course, other procedures maybe performed without departing from the scope of the invention. Theneedle 2 is introduced into the area of interest under suitable guidancesuch as ultrasound visualization. Once the needle 2 has been introducedin a desired or known orientation relative to the tissue area ofinterest, the entire needle 2 is rotated so that the first indicator 14and marker 18 are aligned with a first angular position relative to thetissue area of interest. The first anchor 20 is then deployed into thetissue with the anchor 20 deployed at the selected angular orientation.The second indicator 14 is then rotated to a second selected angularorientation with respect to the area of interest. The second orientationis determined by visualizing the area of interest relative to the needle2 and/or first anchor 20 to determine the appropriate location for thesecond anchor 20. The second anchor 20 is then deployed by advancing theanchor into the tissue. As can be appreciated, the needle 2 and anchors20 themselves provide visual landmarks for locating the area ofinterest. The markings on the needle 2 and the indicators 14 also helpto guide use of the tissue cutting device 6 as described herein.

The stiffener 4 is then removed to provide the flexible proximalportion. The flexible proximal portion may be taped to the patient toprevent inadvertent contact as shown in FIG. 7. When performing theprocedure, the flexible condition may be maintained to provide thebenefit described above such as the ability to pull from varying anglesas compared to a conventional rigid needle. The tissue removal device 6may then be coupled to the needle 2 as shown in FIG. 8 and then advancedwhile being guided by the needle 2. The needle 2 may be introduced to apredetermined depth where the longitudinal stop 38 guides the depth ofintroduction of the tissue removal device. Of course, the needle 2 maybe introduced deeper into the tissue with the user using the depthmarkings 40 on the needle 2 and/or tissue removal device 6 to determinethe appropriate introduction depth for the tissue removal device 6. Thecutting element 8 is then deployed to the bowed position and the cuttingelement 8 is swept through tissue to cut around the tissue area ofinterest. The tissue is then collected by the collection element 10 forremoval. The device 6 is then withdrawn and anchors 30, which aredescribed in more detail in application Ser. No. 10/272,448, filed Oct.16, 2002, are retracted to permit withdrawal of the needle 2 as well.

FIG. 9 is a perspective view of a combination introducer and suctionsleeve 902. The sleeve 92 may be used in the same manner as the guidemembers described herein and such uses is expressly incorporated here.FIG. 10 is a side cross-sectional view thereof. Considering now FIGS. 9and 10 collectively, the first external surface 904 of the combinationintroducer and suction sleeve 902 may have a generally tapered or funnelshape, in that it defines a relatively narrow diameter distal end and arelatively wider proximal end. Such a generally funnel or tapered shapeeases the introduction of the device 802 within tissue. The combinationintroducer and suction sleeve 902 has a suction port 908 that opens toan internal lumen 916 defined by the internal surface 918. Thecombination introducer and suction sleeve 902 also includes a secondexternal surface 912 that defines a tapered appearance. Defined withinthe first and/or second external surfaces 904, 912 are a plurality ofopenings 906 that open to the internal lumen 916. In FIGS. 9-11, onlythe first external surface 904 defines such openings 906, although theopenings are not limited to this surface. The suction port 908 isconfigured to couple with a vacuum line, as shown at 116. Thecombination introducer and suction sleeve 902 may further includestructures to couple to one or more devices. Such coupling structure(s)may include, for example, a snap or interference fitting 914 and/or oneor more O-rings, such as shown at 910.

FIG. 11 is a perspective view of the combination introducer and suctionsleeve of FIG. 9, with a trocar 1102 inserted therein. According to anembodiment of the present invention, the trocar 1102 may be insertedinto the combination introducer and suction sleeve 902 and the assemblymay be packaged as a (preferably single use) unit. According to anotherembodiment of the present invention, a physician may utilize theassembly as follows:

An incision into tissue is made with a blade;

The physician then inserts the assembly including the trocar 1102 intothe tissue and pushes the combination introducer and suction sleeve 902into the tissue through the incision into position under or near thelesion or targeted site within the tissue. The pointed and/or sharpdistal tip 1104 of the trocar 1102 and the tapered profile of thecombination introducer and suction sleeve 902 aid the assembly'sadvancement within the tissue;

The trocar 1102 may then be removed from the combination introducer andsuction sleeve 902 and a desired (excisional RF, for example) device maythen be inserted therethrough, with the shaft thereof disposed withinand protruding from the internal lumen 916;

The combination introducer and suction sleeve 902 may then be pulledback until it contacts, snaps and/or otherwise locks onto the device, asshown at FIGS. 12 and 13. In FIGS. 12 and 13, only the handle 102 of thedevice is shown, and the shaft 104 thereof is omitted for clarity ofillustration. Examples of a tissue cutting device coupled to thecombination introducer and suction sleeve 902 coupled thereto is shownin FIG. 14;

A vacuum line, such as shown at 116, may then be attached to the suctionport 908;

If needed, the device with the combination introducer and suction sleeve902 attached thereto may then be repositioned at, near, under or withinthe target lesion, as desired. This repositioning may be carried outunder ultrasound guidance, for example. The openings 906 may aid withthe ultrasound visualization. The combination may include other featuresand/or markings to increase the visibility thereof under various imagingmodalities, and

The physician may then continue with the intended procedure as per theinstructions for use of the device utilized.

Alternatively, the trocar 1102 may be removed from the combinationintroducer and suction sleeve 902 and the desired RF device introducedand locked therein. The distal tip of the desired RF device protrudingfrom the distal end of the combination introducer and suction sleeve 902may then be used to reach the intended biopsy site.

Alternately still, a stopcock may be attached to the suction port 908instead of the suction line 116 and one or more beneficial agents (e.g.,antibiotics, fibrin, lidocaine) may be delivered to a target sitethrough the openings 906.

The present combination vacuum sleeve and suction sleeve 902 may aid inpositioning a biopsy or other interventional device where it is needed.For example, interventional devices that include a rather bulky orhigh-drag distal end may be readily positioned at the intended site bymeans of the introducer functionality of the combination 902. While thecombination 902 is advantageous before the biopsy or otherinterventional procedure is started by easing the positioning of thebiopsy instrument at or near the target site, it is also useful duringthe procedure itself, as it is effective in evacuating hot gasses andfluids from the biopsy cavity, thereby decreasing collateral tissuethermal damage. The same combination may then also be used to treat thecavity post-procedure by, for example, providing a ready-made pathwayfor the introduction of beneficial agents, compositions and/or cavitytreatment devices to the cavity or lesion site.

Referring now to FIGS. 15-19, another system 200 and method are shownwherein the same or similar reference numbers refer to the same orsimilar structure. As mentioned above, a guide member 202 may be used toguide a cutting device 204. The guide member 202 may be any of thesuitable guide members described herein including the needle 2 of FIGS.1-8 or the introducer 902 of FIGS. 9-14. The cutting device 204 may beany of the cutting devices described herein or another suitable devicesuch as those described in application Ser. No. 10/272,452, filed Oct.16, 2002, which is hereby incorporated herein by reference. The cuttingdevice 204 has a cutting element 205 which bows outwardly when expanded.

The guide member 202 has a tubular body 206 and a removable penetratingelement 208 having a sharp tip 210 for piercing tissue duringintroduction. The guide member 202 also has a port 212 coupled to avacuum source 214 for removing hot gasses generated during cutting. Thepenetrating element 208 has a shaft 216 extending through a lumen 217 inthe guide member 202. The guide member 202 may include one or moreanchors 218 which holds the guide member 202 at the desired position.The anchor 218 may simply be an adhesive strip 220 which the user peelsaway from the body and adheres to the skin. The anchor 218 may also beanother suitable anchor such as one or more needles 221 which areadvanced into the tissue. The anchors 218 help to resist movement of theguide member 202 so that the guide member 220 may be used to guidelongitudinal and even rotational positioning of the cutting device 204as explained herein. Referring to FIG. 20, the anchor 218 may also be aballoon 221 which is inflated to anchor the guide member.

After the guide member 202 has been introduced to the desired depth, thepenetrating element 208 is then removed and the tissue cutting device204 is introduced and advanced into the guide member 220 (FIG. 17). Theguide member 202 may include a stop 222 which prevents furtheradvancement of the tissue cutting device 202 so that the device 204remains in the same longitudinal position. The guide member 202 may alsoinclude one or more angular indicators 224 which may be the anchors 218.Referring to FIG. 20, another guide member 202A is shown which has awindow 226 oriented in the desired direction of cutting. The window 226guides the user by limiting and/or defining the cutting motion to helpguide the cutting procedure. The use and structural features of theguide member 220, indicators 224, anchors 118 and stop 222 may be thesame or similar to those described in connection with FIGS. 1-8.

Referring again to FIG. 14, the cutting element 108 preferably has anultrasound marker 232 at an anticipated apex of the cutting element 108when the cutting element 108 is expanded to help position the device.The apex 232 does not necessarily correspond with the geometric middleof the cutting element 108 when the cutting element 108 is collapsedsince only one end of the cutting element 108 may be moved to bow thecutting element 108 outward. For example, the proximal end of thecutting element 108 may be advanced distally to bow the cutting element108 outward in which case the first marker 232 would appear to be closerto the proximal end when the cutting element 108 is collapsed. Thecutting device 204 may also include a second marker 234 and a thirdmarker 236 which correspond to the ends of the cutting element 108 whenthe cutting element 108 is collapsed. Referring again to FIG. 17, theguide member 20 may have a first marker 229, corresponding to ananticipated apex 229 of the cutting element 108, and a second marker 228and a third marker 230 corresponding to the ends 228, 230 of the cuttingelement 108 when collapsed. In this manner, the guide member 202 mayhelp properly position the cutting device. Of course, any of the guidemembers or tissue cutting devices described herein, such as the needle2, may also have the ultrasound markers positioned in this manner. Thecutting element and the guide may be marked in any suitable manner. Forexample, the cutting element or guide may include a hollow area whichwould enhance the ultrasound signature. When placing a marker on thecutting element, the marker may be designed to be easily visible whenthe cutting element 205 is powered at a level lower than the power levelused during cutting. For example, the cutting element 205 may bedesigned to become more visible when an RF generator is switched tocoagulation mode which has lower power than the cutting mode used whencutting tissue.

Referring now to FIGS. 20-24, the tissue cutting device 204 may have ashaft 240 with an asymmetrical cross-sectional shape adjacent to thecutting element 205 to aid parting off the tissue when completing thecutting operation. The shaft 240 is thicker in the direction in whichthe cutting element 205 expands as compared to the direction oppositecutter expansion. Stated another way, the shaft 240 may be thicker on aleading side 242, which leads the cutting element when rotated in thedirection of arrow 245, than on an opposing or trailing side 244. Theshaft 240 may also be thicker on the leading side in a directionsubstantially perpendicular to expansion of the cutting element 205A(shown mounted to shaft 240 in the dotted-line position). Cuttingelement 205A is mounted to the shaft 240 in an orientation about 90degrees from the orientation of the cutting element 205. Of course, thecutting element 205A may be mounted to the shaft 240 in otherorientations relative to the thicker part of the shaft such as anyposition between element 205 and element 205A. Stated still another way,the cutting element 205 may be oriented and mounted on the shaft 240 inany manner which provides a thicker side within the first 90 degrees ofthe leading side compared to the shaft thickness in the 90 degreestrailing the cutting element 205. In the various suggestedconfigurations described, the thicker part of the shaft 240 ispreferably at least 1.25 times, 1.50 times, or even 1.75 times thickerthan the thinner part of the shaft 240.

The shaft 240 may be formed in any suitable manner. Referring to FIGS.20-24, for example, a metallic tube 248 is cut to form a lip 250 whichis bent outwardly to provide the thicker shaft section. The tube 248 isthen covered with a shrink tube 252 and heated to bond the shrink tube252 to the tube 248. The shrink tube 252 covers the opening in the tubecreated by formation of the lip 252. The shrink tube 252 also forms abeveled surface 254 which covers an opening 253 in the tube 248 createdby the lip 250.

Use of the system 200 is now described with reference again to FIGS.15-19. The guide member 202 is introduced into the tissue to anappropriate depth relative to the tissue to be removed. As explainedabove, the guide member 202 may be used to help define and/or guideaspects of the cutting motion such as the depth of insertion and/or oneor more angular positions indicating the angular extent of the targetedtissue. For example, the ultrasound marker 229 may be used to positionthe guide member 202 so that the anticipated apex of the cutting element205 is positioned appropriately. When the guide member 202A of FIG. 19is used, the cutting window 226 is positioned in the desired angularorientation which positions the tissue to be removed within the window226. The window 226 may have an opening a bit larger than theanticipated requirement so that the window 226 guides, but notnecessarily overly limits, the angular and longitudinal position of thecutting device 204.

Once the guide member 202, 202A has been positioned properly relative tothe desired cutting operation the tissue penetrating element 208 may beremoved and the cutting device 204 is introduced into the guide member202. The guide member 202 is then retracted a predetermined amount sothat the guide member 202 is properly positioned to remove hot gasesgenerated during RF cutting as described above. When using the guidemember 202A having the cutting window 226, the guide member does not, ofcourse, need to be retracted.

The cutting device 204 is then used to cut around the tissue to beremoved. The tissue may be removed in a tissue collection element 10(see FIG. 2). Alternatively, vacuum means may also be used to remove thetissue as now described and further described in application Ser. No.10/796,328, filed Mar. 8, 2004, which has been incorporated herein byreference. The cutting device 204 may be any suitable cutting devicesuch as those described in application Ser. No. 10/272,452, filed Oct.16, 2002.

Referring now to FIGS. 25-29, another system is shown which uses asheath 495 to receive one or more devices such as a core 400, which maybe used for imaging, and an excisional device 100 which is used to cutthe tissue. The core 400 has an active element 440 configured to performintra-tissue imaging and of relaying information back to a displaydevice (shown in FIG. 29) via a communication channel, such as shown atreference numeral 460. The communication channel 460 may be wireless ormay include, for example, optical fibers and/or electrical conductors.The active element 440 may draw power from an internal battery (notshown) or from a power source, such as shown at reference numeral 480.The active element 440 may include an ultrasound transducer. Other typesof transducers may be used instead of or in addition to an ultrasoundtransducer. The removable transducer core 400 preferably includes agenerally tubular shaft 430. A proximal section 450 is included near theproximal portion of the transducer core 400.

To accommodate the removable transducer core 400, the excisional device100 of FIG. 25 includes an internal lumen 420 through which theremovable transducer core 400 may be inserted. Preferably, theexcisional device 100 is used once and disposed of, for safety andfunctional reasons. The removable transducer core 400, however, mayeither be disposable or re-usable for a limited number of uses. To allowthe active element 440 of the transducer core 400 to image the lesion tobe excised and the surrounding tissue, a generally tubular member 110 ofthe excisional device 100 includes a transducer window 410. When theremovable transducer core 400 is inserted within the internal lumen 420,the proximal section 450 of the core 400 preferably snaps into a lockedconfiguration with the proximal end of the excisional device 100. Whenin its locked configuration, the active element 440 of the transducercore 400 is aligned with and faces the transducer window 410, to allowthe active element 440 to image the lesion and the surrounding tissuetherethrough.

FIG. 26 shows an embodiment of the removable core 400 according to thepresent invention. As the removable core 400 may advantageously be usedindependently of the excisional device 100, the removable core 400includes a distal tapered tip 470, to allow it to easily penetrate softtissue. Moreover, its thin profile allows the surgeon to insert theremovable core 400 within soft tissue without, however, unduly damagingthe tissue or making a large incision. The removable core 400 allows thesurgeon to precisely localize the lesion to be excised from within thetissue itself For example, the active element 440 of the removable core400 may include an ultrasound transducer and may be used alone or inaddition to surface ultrasound to localize the lesion with a greatdegree of precision.

FIG. 27 shows a cross section of the embodiment of the excisional device100 of FIG. 25, taken along line AA'. As shown in FIG. 27, the cuttingtool 125 is exposed through the transducer window 120. The window 120may, as shown in FIG. 27, include support guides 122 to support andguide the cutting tool 125 as it is outwardly extended and bowed. Thetissue collection device 260, for clarity, is not shown in either FIG.25 or 27. However, to accommodate the bulk of the excised tissue samplecollected in the tissue collection device 260 after the cutting andcollecting operation described herein, the tubular member 110 mayinclude a recessed section 131. The recessed section provides space forthe collected (e.g., bagged) tissue sample in the tissue collectiondevice 260 when the excisional device is removed from the soft tissuemass. In this manner, the collected tissue sample within the tissuecollection device 260 does not protrude from the generally smooth outersurface of the excisional device 100 upon retraction of the latter fromthe soft tissue mass from which the tissue sample is excised. Theinternal lumen 420 allows the removable core 400 to slide therein and toproperly position the active element 440 facing the transducer window410.

FIG. 28 shows the removable core 400 inserted within the expandablesheath 495. The expandable sheath 495 includes a proximal base section510. Attached to the proximal base section 510 is a generallycylindrical expandable meshwork 500 of, for example, plastic or nylonfibers. The meshwork 500 may be somewhat tapered at its distal end 520,to provide a smooth transition between the expandable meshwork 500 andthe removable core device 400. The proximal section 450 of the core 400may snap-fit to the proximal base section 510 of the expandable sheath495, so as to be securely and removably attached thereto. As shown inFIG. 28, the expandable meshwork 500 expands just enough to accommodatethe removable core 400 inserted therein. In practice, the expandablesheath 495 and removable core 400 assembly may be inserted within thesoft tissue together, to allow the surgeon to image the lesion prior toinserting the somewhat greater diameter excisional device 100 therein.Thereafter, the surgeon may retract the removable core 400 from theexpandable sheath 495, leaving the expandable sheath 495 in place withinthe soft tissue, such as the breast.

FIG. 29 shows another embodiment of a soft tissue excisional deviceassembly 600 according to the present invention. In the configurationshown in FIG. 29, the removable core 400 is inserted and secured withinthe excisional device 100 so that the active element 440 faces out ofthe transducer window 410. Preferably, the excisional device 100 isremovable from the expanded sheath 495 shown in FIG. 14, while leavingthe expanded sheath 495 in place within the soft tissue. In this manner,after retraction of the excisional device 100 from the sheath 495, thesheath 495 remains in place within the soft tissue to allow otherinstruments to be inserted therethrough. For example, the removable core400 may, after the excisional procedure proper, be re-inserted throughthe expanded sheath 495 to the excision site. The tissue collectiondevice 260 is not shown, for clarity but may be used in any mannerdescribed herein or in the applications or patents incorporated hereinwithout departing from the scope of the invention.

In FIG. 29, the excisional device 100 is shown inserted within theexpandable sheath 495. Indeed, the excisional device 100, in FIG. 29, isshown inserted within and past the distal end 520 of the meshwork 500,so the distal portion of the excisional device 100 including the cuttingelement or tool 125 and the transducer window 410 extends therethrough.The meshwork 500, in FIG. 29, has expanded to accommodate the diameterof the excisional device 100. The proximal portion of the excisionaldevice 100 may extend from the proximal base section of the expandablesheath 495. This allows the push or turn knob 526 (a turn knob 526 shownin FIG. 29) to be manually accessible to the surgeon.

A number of peripheral devices may be connected to the assembly 600.Examples of such include a core power source 480, which may be, forexample, an electrical source for an ultrasound transducer, one or moredata processing and display devices 550 on which the internal structureof the tissue imaged by the active element 440 of the core 400 may bedisplayed, suction means 490, a cutting tool power source (a variable RFenergy source, for example or any suitable RF power source found in mostoperating rooms), and/or other devices 590. The suction device 490 mayprovide a suction force to the window 120 through an internal lumen tofacilitate cutting of the tissue by the cutting tool 125. Any othersuitable cutting or excisional device may be used in connection with thepresent invention such as those described in copending application Ser.No. 10/272,452, filed Oct. 16, 2002, which has been incorporated hereinby reference.

The vacuum means may be associated with the cutting tool 125 (FIG. 25)or the cutting device 204 (FIG. 17) or may be a separate removal device300 as shown in FIG. 30. As will be further described, the tissue mayalso be removed through the same incision or a separate incision fromthe incision through which the cutting device 204 extends. Referringstill to FIG. 31, the tissue removal device 300 may have one or moresuction ports 302 at a distal end 308. The suction port 302 is coupledto a lumen 304 which in turn is coupled to a vacuum source 306. Thesuction port 302 can be flared outwardly to enhance suction adherenceand to help retract tissue away from the tissue being removed as shownin FIG. 32. The end 308 may have longitudinal slots (not shown) coveredby an elastic cover 309 which permits the end 308 to flare outwardly ina manner similar to expandable trocars and cannulae as is known in theart. The end 308 may be actuated with a thumb switch 310 or othersuitable actuator. Of course, the tissue removal device 300 may alsodirectly grasp or pierce the tissue with piercing elements 311, such asneedles 313, rather than relying on suction adherence. For example, thetissue removal device 300 may advance needles 312 into the tissue toanchor and grasp the tissue.

The tissue removal device 300 may be introduced through the sameincision as the tissue cutting device 204 or may be introduced through adifferent incision. For example, the user may choose to introduce thecutting device 204 based primarily on the desired orientation of thecutting device 200 relative to the tissue area being removed. The usermay then choose the removal incision based on other factors such asproximity to the skin or for cosmetic considerations. Referring to FIGS.33-35, the removal incision may be partially or completely created withthe tissue cutting device 204. For example, the cutting element 205 maybe expanded and energized when the shaft is being withdrawn and/oradvanced so that the cutting element 205 creates a tissue channel. Thisprocedure may be repeated to create the desired channel such as an X- orY-shaped channel. The cutting element 205 may have a movable insulatingsheath 260 which covers a portion of the cutting element 205, such asthe distal portion of the element 205, to prevent inadvertent cutting ofthe tissue being removed when creating the tissue channel. Use of amovable insulating sleeve 260 is described in application Ser. No.10/349,659, filed Jan. 23, 2003, which is hereby incorporated herein byreference.

Referring to FIG. 36, the cutting element 205 may also be used to createa separate incision for removal of the tissue by cutting a channeldirectly from the area in which the tissue has been cut and extendingoutwardly from the severed portion. The cutting element 205 ispositioned so that further extension and bowing of the cutting element205 will essentially create a path outwardly from the severed portion ofthe tissue. This procedure may be performed after severing the tissue inthis area so that the cutting element 205 can be initially positionedwithout RF power. The ultrasound markers described herein, and inparticular the marker near the apex of the cutting element 205 whenexpanded and bowed, are particularly useful in properly positioning thecutting element 205 at this time. The cutting element 205 may then bepowered with RF to partially or completely create the tissue channel.This procedure may be desirable when the cutting procedure causes thecutting element 205 to pass near the skin. The cutting device 204 mayalso include a movable insulating sleeve 261 which covers part of thecutting element 205, such as portions on the ends of the cutting element205, during this part of the procedure to reduce the excess lateralcutting during creation of the tissue channel.

When removing the tissue, the tissue may be contained within a tissuecollection element 320 released by the cutting device 204 when thetissue is severed or which is deployed by itself after excision of thetissue. The tissue collection element 320 may simply trail the cuttingelement 205 similar to the patents and applications incorporated byreference herein in which the tissue collection element remains coupledto the device.

FIG. 37 shows the collection element 320 containing the tissue with atether 322 extending from the tissue collection element 320 and beingwithdrawn as the cutting device 204 is removed. The tether 322 may beused to guide advancement and engagement of the tissue removal device300. For example, the tissue collection element 320 may have a connector324 which engages the removal device 300 with a suitable mechanical,magnetic or suction connection. The connector 324 may be positioned atthe end of the tether 322 so that engagement with the connector 324 iseasily guided by the tether 322.

Referring still to FIG. 37, the tether 322 may be particularly usefulwhen removing the tissue through a separate incision since the tether322 can be easily retrieved using a conventional suture snare or thelike. The tether 322 may also be used without the tissue collectionelement 320 by simply attaching the tether 320 to the tissue with aneedle, screw 321 (see FIG. 37) or other suitable attachment feature.The tether 320 may be delivered by the cutting device 204 or may be partof another device such as the tissue removal devices described herein.

Referring to FIGS. 39-41, still another aspect of the present inventionis shown. The tissue cutting device 204 is shown and all features andaspects of the tissue cutting devices described herein are incorporatedhere. The tissue cutting device 204 is shown sweeping around the tissueto be removed. The cutting element 205 is then partially retracted sothat only a small piece of tissue connects the tissue to be removed fromthe surrounding tissue as shown in FIG. 41. The tissue cutting device205 may then be used to manipulate the tissue to assist or prepare thetissue for removal. The tissue cutting device 204 may be designed tolock the cutting element 205 in the partially opened position of FIG. 41to trap the tissue between the cutting element 205 and the shaft 240 sothat the cutting device 204 may be used to manipulate the tissue. Forexample, the tissue may be manipulated while the tissue is beingencapsulated in a tissue collection element or when the tissue is beingengaged by any of the tissue removal devices described herein such asthe device 300. When it is desired to remove the tissue, the cuttingelement 205 is collapsed further to complete the cut.

The tissue cutting device 204 may also mark the tissue sample and/or thetissue surrounding the tissue sample as shown in FIG. 42. Marking thetissue may assist in identifying the tissue for removal or to mark thetissue remaining in the body for subsequent therapy or treatment. Thetissue may be marked in any suitable manner such as those described inapplication Ser. No. 10/871,790, filed Jun. 17, 2004, which isincorporated herein by reference. For example, the tissue cutting device204 may have one or more dye injection ports 330 to mark the tissue. Ofcourse, the cutting device may also leave behind a marker, such as aspiral spring or coil as described above, to mark the tissue rather thanmarking the tissue with a dye or the like. It is understood that markingthe tissue being removed and/or marking the tissue remaining in the bodymay be used in connection with any of the other features and aspects ofthe present invention including use with any of the tissue cutting orremoval devices described herein.

The present invention has been described in connection with thepreferred embodiments, however, it is understood that many alternativesare possible without departing from the scope of the invention.

1-16. (canceled)
 17. A device for cutting tissue having a bowed cuttingelement, comprising: a shaft having a central axis; and a tissue cuttingelement coupled to the shaft, the tissue cutting element being movablefrom a collapsed position to an expanded position, the cutting elementbowing outwardly when in the expanded position, the cutting elementmoving generally in a first plane when moving between the collapsed andexpanded positions; the shaft having a first thickness and a secondthickness relative to the central axis of the shaft, the first andsecond thicknesses lying in a second plane which is generally parallelto the first plane, the second thickness being at least 1.25 timeslarger than the first thickness and the side of the shaft having thesecond thickness leading the cutting element during rotation.
 18. Thedevice of claim 17, wherein: the second thickness is at least 1.5 timeslarger than the first thickness.
 19. The device of claim 17, wherein:the tissue cutting device has a tissue collection element which holdsthe tissue volume cut free from the surrounding tissue.
 20. A device forcutting tissue using a bowed cutting element, comprising: a shaft; and atissue cutting element coupled to the shaft, the tissue cutting elementbeing movable from a collapsed position to an expanded position, thecutting element bowing outwardly when in the expanded position, thetissue cutting element moving generally in a first plane when movingbetween the collapsed and expanded positions; wherein the shaft is atleast 1.25 times thicker on a leading side than on a trailing side, thethickness being measured along a second plane perpendicular to the firstplane, the cutting device being rotated during cutting so that theleading side leads the cutting element.
 21. The device of claim 20,wherein: the shaft is at least 1.5 times thicker on the leading sidethan on the trailing side.
 22. The device of claim 20, wherein: theshaft is thicker on the leading side adjacent to the cutting element andis substantially the same as the trailing side at substantially allother parts of the shaft.
 23. A method of cutting tissue using a bowedcutting element, comprising the steps of: providing a tissue cuttingdevice having a shaft and a tissue cutting element coupled to the shaft,the tissue cutting element being movable from a collapsed position to anexpanded position, the cutting element bowing outwardly when in theexpanded position, the tissue cutting element moving generally in afirst plane when moving between the collapsed and expanded positions,wherein the shaft has a first and second thicknesses lying in a secondplane which is generally parallel to the first plane, the secondthickness being on a side of the shaft from which the tissue cuttingelement expands, the second thickness being at least 1.25 times largerthan the first thickness; introducing the tissue cutting device intotissue; expanding the tissue cutting element toward the expandedposition; rotating the tissue cutting device so that the cutting elementmoves through the tissue to cut the tissue, the cutting device beingrotated in a direction in which a side having the second thickness leadsthe cutting element during rotation; moving the tissue cutting elementback toward the collapsed position to cut a tissue volume free from thesurrounding tissue.
 24. The method of claim 23, wherein: the providingstep is carried out with the second thickness being at least 1.5 timeslarger than the first thickness.
 25. The method of claim 23, wherein:the providing step is carried out with the tissue cutting device havinga tissue collection element which holds the tissue volume cut free fromthe surrounding tissue.
 26. The method of claim 23, wherein: theproviding step is carried out with the shaft having at least the secondthickness adjacent to the cutting element. 27-72. (canceled)